Stemline is a commercial-stage biopharmaceutical company committed to applying our scientific leadership and commercial expertise to transform the lives of patients with cancer.
ELZONRIS a targeted therapy directed to CD123, is FDA-approved and commercially available in the U.S. for the treatment of adult and pediatric patients, two years and older, with BPDCN. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA).
Inspired by the goal to improve outcomes for patients with unmet medical needs,
Stemline is driven to discover and develop innovative therapeutics for the treatment of cancer. Currently our clinical-stage product candidates in include ELZONRIS, SL-701 and SL801.
ELZONRIS a targeted therapy directed to CD123, is FDA-approved and commercially available in the U.S. for the treatment of adult and pediatric patients, two years and older, with BPDCN. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA).
Inspired by the goal to improve outcomes for patients with unmet medical needs,
Stemline is driven to discover and develop innovative therapeutics for the treatment of cancer. Currently our clinical-stage product candidates in include ELZONRIS, SL-701 and SL801.
Location: United States, New York
Employees: 51-200
Founded date: 2003
Investors 1
| Date | Name | Website |
| - | Avoro Capi... | avorocapit... |
Mentions in press and media 17
| Date | Title | Description |
| 03.02.2026 | Insilico Medicine Receives USD 5million Milestone Payment from Menarini Group Following First-in-Human (FIH) Achievement for MEN2501 | Followed by the development and regulatory milestone payment of USD 3 million in July 2025, Insilico received an additional milestone payment of USD 5 million from Menarini Group after first-in-patient dosing in a Phase 1 trial of MEN2501, ... |
| 09.12.2025 | Menarini Group Presents Elacestrant (ORSERDU®) Phase 2 Combination Data in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2025 San Antonio Breast Cancer Symposium | In addition, the expansive elacestrant clinical development program updates reinforce its potential as a backbone endocrine therapy in combination settings, as well as in both metastatic and early stage breast cancer. FLORENCE, Italy and NE... |
| 24.11.2025 | Menarini Group Announces New Data on ELZONRIS® (tagraxofusp-erzs) to be Presented at the 67th American Society of Hematology Annual Meeting and Exposition | Data spans five abstracts including two oral presentations with important findings for patients living with blastic plasmacytoid dendritic cell neoplasm (BPDCN) BPDCN is a highly aggressive, orphan hematologic malignancy that primarily affe... |
| 29.05.2025 | New Frontiers in Cancer Treatment: Elacestrant and Kidney Cancer Monitoring | In the relentless battle against cancer, innovation is the sword and shield. Two recent developments shine a light on this ongoing fight: the promising data surrounding elacestrant for breast cancer and the completion of a significant kidne... |
| 23.05.2025 | Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting | Preliminary efficacy analysis from the elacestrant plus everolimus and ribociclib cohorts of the ELEVATE study, along with updated safety data from additional cohorts of elacestrant plus targeted therapy combination arms, will be presented.... |
| 26.11.2024 | Menarini Group Presents New and Expanded Data at the 2024 San Antonio Breast Cancer Symposium Reinforcing the Role of ORSERDU® (Elacestrant) for Patients with ER+, HER2- Advanced or Metastatic Breast ... | Real-world evidence bolsters the efficacy of ORSERDU for the treatment of patients with ER+/HER2- ESR1-mut advanced or mBC. Updated results of elacestrant in combination with abemaciclib show favorable efficacy regardless of the ESR1 mutati... |
| 24.05.2024 | Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting | The ELECTRA and ELEVATE studies were designed to overcome different resistance mechanisms and improve patient outcomes with oral-oral combination options. Updated results from the ELECTRA study, evaluating elacestrant in combination with ab... |
| 04.05.2020 | Italy’s Menarini Group to acquire Stemline Therapeutics for $677M | Shares of Stemline were up 153.7% on the Nasdaq by late morning following the news. Menarini is a privately held company. Stemline won Food and Drug Administration approval in December 2018 for Elzonris (tagraxofusp-erzs), a drug used to tr... |
| 20.02.2019 | Xencor leukemia trial put on partial hold following two patient deaths | Under the partial clinical hold, patients who are currently taking the AML drug can continue treatment, but the study will not enroll any new patients until the hold is lifted. According to ClinicalTrials.gov, the trial is designed to enrol... |
| 03.02.2017 | Stemline comes clean on patient death, but questions linger; Life sciences fund launches with €100M | Adam Feuerstein, Twitter • Stemline $STML has been forced to admit that it received a report that one of the patients in its pivotal study of SL-401 for blastic plasmacytoid dendritic cell neoplasm (BPDCN) died after devel... |
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